For Patients

Neulasta (pegfilgrastim) is used to decrease the incidence of infection, by treating neutropenia, a lack of certain white blood cells caused by receiving cancer chemotherapy. It is a colony-stimulating factor. It is a man-made form of a protein that stimulates the growth of white blood cells. Common side effects include bone pain.

The recommended dosage of Neulasta is a single subcutaneous (under the skin) injection of 6 mg administered once per chemotherapy cycle. Neulasta may interact with lithium (Eskalith, Lithobid, and others). There may be other drugs that can interact with Neulasta. Tell your doctor about all prescription and over-the-counter medications and supplements you use. Neulasta should be used only when prescribed during pregnancy. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Neulasta (pegfilgrastim) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

SIDE EFFECTS: Bone pain may occur. Taking a non-aspirin pain reliever such as acetaminophen may help with this pain. Ask your doctor or pharmacist for more details. Injection site reactions such as redness, swelling, itching, lumps, or bruising may also occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if any of these rare but very serious side effects occur: breathing problems (e.g., trouble breathing, shortness of breath, fast breathing).

Rarely, possibly fatal damage to the spleen may occur. Get medical help right away if you experience the following side effects: stomach/abdominal pain and/or shoulder pain.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, fast heartbeat, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

The most common adverse reactions occurring in ≥ 5% of
patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim
arm in placebo controlled clinical trials are bone pain and pain in extremity.

Clinical Trials Experience

Because clinical trials are conducted under widely varying
conditions, adverse reaction rates observed in the clinical trials of a drug cannot
be directly compared with rates in the clinical trials of another drug and may
not reflect the rates observed in clinical practice.

Neulasta clinical trials safety data are based upon 932
patients receiving Neulasta in seven randomized clinical trials. The population
was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18%
Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and
thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after
nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100
mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4
cycles.

The following adverse reaction data in Table 1 are from a
randomized, double-blind, placebo-controlled study in patients with metastatic
or non-metastatic breast cancer receiving docetaxel 100 mg/m² every 21 days
(Study 3). A total of 928 patients were randomized to receive either 6 mg
Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of
age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black,
and < 1% Asian, Native American or other.

Bone pain and pain in extremity occurred at a higher
incidence in Neulasta-treated patients as compared with placebo-treated
patients.

Leukocytosis

In clinical studies, leukocytosis (WBC counts > 100 x 109/L)
was observed in less than 1% of 932 patients with non-myeloid malignancies
receiving Neulasta. No complications attributable to leukocytosis were reported
in clinical studies.

Immunogenicity

As with all therapeutic proteins, there is a potential for
immunogenicity. Binding antibodies to pegfilgrastim were detected using a
BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL.
Pre-existing binding antibodies were detected in approximately 6% (51/849) of
patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated
subjects who were negative at baseline developed binding antibodies to
pegfilgrastim following treatment. None of these 4 patients had evidence of
neutralizing antibodies detected using a cell-based bioassay.

The detection of antibody formation is highly dependent on
the sensitivity and specificity of the assay, and the observed incidence of
antibody positivity in an assay may be influenced by several factors, including
assay methodology, sample handling, timing of sample collection, concomitant
medications, and underlying disease. For these reasons, comparison of the
incidence of antibodies to Neulasta with the incidence of antibodies to other products
may be misleading.

Postmarketing Experience

The following adverse reactions have been identified during
post approval use of Neulasta. Because these reactions are reported voluntarily
from a population of uncertain size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to drug exposure.
Decisions to include these reactions in labeling are typically based on one or
more of the following factors: (1) seriousness of the reaction, (2) reported
frequency of the reaction, or (3) strength of causal relationship to Neulasta.